Swank Hilko A, Vermeulen Jefrey, Lange Johan F, Mulder Irene M, van der Hoeven Joost A B, Stassen Laurents P S, Crolla Rogier M P H, Sosef Meindert N, Nienhuijs Simon W, Bosker Robbert J I, Boom Maarten J, Kruyt Philip M, Swank Dingeman J, Steup Willem H, de Graaf Eelco J R, Weidema Wibo F, Pierik Robert E G J M, Prins Hubert A, Stockmann Hein B A C, Tollenaar Rob A E M, van Wagensveld Bart A, Coene Peter-Paul L O, Slooter Gerrit D, Consten Esther C J, van Duijn Eino B, Gerhards Michael F, Hoofwijk Anton G M, Karsten Thomas M, Neijenhuis Peter A, Blanken-Peeters Charlotte F J M, Cense Huib A, Mannaerts Guido H H, Bruin Sjoerd C, Eijsbouts Quirijn A J, Wiezer Marinus J, Hazebroek Eric J, van Geloven Anna A W, Maring John K, D'Hoore André J L, Kartheuser Alex, Remue Christophe, van Grevenstein Helma M U, Konsten Joop L M, van der Peet Donald L, Govaert Marc J P M, Engel Alexander F, Reitsma Johannes B, Bemelman Willem A
Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
BMC Surg. 2010 Oct 18;10:29. doi: 10.1186/1471-2482-10-29.
Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).
METHODS/DESIGN: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.
The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.
Nederlands Trial Register NTR2037.
最近，有报道称腹腔镜灌洗治疗化脓性穿孔性憩室炎患者取得了良好效果，可作为乙状结肠切除术和造口术的替代方法。本研究的目的是确定腹腔镜灌洗引流术（LOLA组）对化脓性腹膜炎患者是否为一种安全有效的治疗方法，并确定化脓性或粪性腹膜炎患者的最佳切除策略（DIVA组：穿孔性憩室炎：行乙状结肠切除并视情况行吻合术）。
方法/设计：在这项多中心随机试验中，纳入所有穿孔性憩室炎患者。腹腔镜检查时，化脓性腹膜炎患者按2:1:1的比例接受腹腔镜灌洗引流、Hartmann手术或乙状结肠切除并一期吻合术治疗（LOLA组）。粪性腹膜炎患者将在Hartmann手术和一期吻合术切除之间按1:1随机分组（DIVA组）。LOLA组的主要联合终点是严重并发症和死亡率。132:66:66例患者的样本量将能够检测出切除组主要终点的差异为25%，而腹腔镜灌洗组为10%（双侧α = 5%，检验效能 = 90%）。DIVA组的终点是初次手术后一年无造口生存。在该组中，需要212例患者才能显著证明一期吻合术切除的患者有30%的差异（对数秩检验双侧α = 5%，检验效能 = 90%）。两组的次要终点是存活并出院天数、健康相关生活质量、医疗保健利用情况及相关费用。
Ladies试验是一项关于穿孔性憩室炎的全国性多中心随机试验，将为腹腔镜灌洗引流治疗化脓性弥漫性腹膜炎的优点以及化脓性和粪性弥漫性腹膜炎的最佳切除策略提供证据。
荷兰试验注册NTR2037。
